Butterfly needle with passive guard

ABSTRACT

A butterfly needle device having a passive needle protection system includes a needle that has a proximal end, a distal tip and defines a needle axis. A cylindrical base member having an axially aligned groove is disposed over the needle with a first wing extending radially from the base member. A second wing is provided for rotation about the needle axis relative to the first wing between a closed configuration in which the wings are juxtaposed and an open configuration in which the wings are displaced from each other. A cylindrical needle guard having a plug is disposed over the needle. A spring biases the needle guard distally relative to the base member. A wing-activated mechanism is provided to align the plug with the groove after a closed-open-closed wing cycle allowing the needle guard to distally advance to cover the needle tip at the end of the cycle.

This application is a divisional of application Ser. No. 10/434,717,filed May 9, 2003, which is currently pending. The contents ofapplication Ser. No. 10/434,717 are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention pertains generally to butterfly needle devices(including winged needles and winged I.V. sets) for medical use. Moreparticularly, the present invention pertains to passive safety systemsfor butterfly needle devices. The present invention is particularly, butnot exclusively, useful for passively covering and protecting the needleof a butterfly needle device after the device has been used in a medicalprocedure.

BACKGROUND OF THE INVENTION

Accidental needle sticks can occur in several ways. For example, asudden movement by a patient can cause a healthcare worker to losecontrol of the needle, resulting in injury. Additionally, injuries canresult when contaminated, unprotected needles are left unattended ordisposed of improperly. Moreover, attempts to manually recap a needleafter a medical procedure can also result in injury. In addition toaccidental needle sticks, unnecessary exposure to bloodborne pathogenscan result when a healthcare worker mistakenly re-uses a contaminatedneedle on a patient.

Accidental needle sticks and the inadvertent reuse of a contaminatedneedle have the potential to expose patients and healthcare workers tolife-threatening viruses that include hepatitis and HIV. Because of thispotential exposure, healthcare providers are obligated to conductextensive testing of exposed individuals. Additional follow-up testingfor HIV is typically prescribed approximately six months after theexposure. It is to be appreciated that the costs associated with thetesting, lab work, the workers lost time, and the associated trackingand administrative costs, can be considerable.

One type of needle device that can cause accidental needle sticks is thebutterfly needle. The butterfly needle is typically used when it isrequired to introduce a fluid into or withdraw a fluid from a patientover a relatively long period of time. For example, the butterfly needlecan be connected to a syringe, an IV set or a blood collection holder.One advantageous feature of a butterfly needle is that it contains wingsthat can be folded flat and taped to the patient's skin to stabilize thedevice. This is especially important when the needle must remain inplace for a relatively long period. Typically, the wings of a butterflyneedle are initially juxtaposed to allow the healthcare worker to holdthe device during insertion of the needle into the patient. After needleinsertion, the wings are folded flat against the patient's skin andtaped. To remove the butterfly needle, the tape is pulled up and thewings are folded together (i.e. juxtaposed). With the wings together,the needle can be easily withdrawn from the patient.

In light of the above, it is an object of the present invention toprovide a passive needle protection system for a butterfly needle thatis activated by the normal opening and closing of the butterfly needlewings. It is yet another object of the present invention to provide aneedle protection system for a butterfly needle device that locks aguard in place to cover and protect the tip of the needle and to preventinadvertent reuse of the device. Yet another object of the presentinvention is to provide a protective device for a butterfly needle thatis easy to use, relatively simple to implement and comparatively costeffective.

SUMMARY OF THE PREFERRED EMBODIMENTS

A butterfly needle device having a passive needle protection systemincludes an elongated needle that has a proximal end, a distal tip anddefines a needle axis. The device further includes a hollow, cylindricalbase member that is disposed over the needle and centered on the needleaxis. A substantially flat first wing is attached to and extendsradially from the cylindrical base member. The device further includes afirst hollow cylinder that is disposed over the needle proximal to thebase member and is centered on the needle axis. A second substantiallyflat wing is attached to and extends radially from the first hollowcylinder.

The above-described interactive cooperation of structure allows thesecond wing to rotate about the needle axis relative to the first wing.More specifically, the second wing can rotate relative to the first wingbetween a first, closed configuration in which the wings are juxtaposedand a second, open configuration in which the wings are displaced fromeach other by approximately one-hundred eighty degrees (180°). Theclosed configuration allows the healthcare worker to easily grip thewings when the needle is inserted into and withdrawn from the patient.On the other hand, the open configuration allows the wings to be tapedto the patient to stabilize the device during a medical procedure whichcan involve the introduction of a medicament into the patient or theaspiration of a body fluid from the patient.

The device also includes a hollow, cylindrical needle guard that isdisposed over the needle and positioned coaxially with the base memberand first hollow cylinder. For the butterfly needle device, the needleguard is sized to pass through both the base member and first hollowcylinder, thus allowing for reciprocal axial movement of the guardrelative to the base member and first hollow cylinder. In one embodimentof the device, the base member has a cylindrical shaped inner wall thatis formed with an axially aligned groove that extends from the basemember's proximal end to the base member's distal end. A plug extendsradially from the needle guard for interaction with the groove formed onthe base member.

Also for the butterfly needle device, a helical spring is provided tobias the needle guard distally relative to the base member. In a typicalembodiment of the device, the helical spring is interposed between theneedle guard and a needle/tubing adapter that is attached to theproximal end of the needle. With this structural combination, the needleguard is biased in the distal direction relative to the needle, the basemember, the wings and the first hollow cylinder.

The device further includes a mechanism for rotating the needle guard(about the needle axis) to align the plug with the groove after thewings have been cycled from the closed configuration to the openconfiguration and then back to the closed configuration. This alignmentof the plug and groove at the completion of the closed-open-closed wingcycle allows the needle guard to distally advance relative to theneedle. Thus, at the end of the closed-open-closed wing cycle, theneedle guard is free to advance to a distal position wherein the needleguard covers and protects the distal tip of the needle.

In greater structural detail, the aligning mechanism includes the firsthollow cylinder (see partial description above) and a second hollowcylinder. The first hollow cylinder has an inner wall that is formedwith an axially aligned slot that is provided to interact with the plug.With the plug in the slot, the guard rotates relative to the base memberduring movement of the second wing relative to the first wing. For thebutterfly needle device, the second hollow cylinder is attached to thefirst wing and centered on the needle axis proximal to the first hollowcylinder. The second hollow cylinder has an inner wall that is formedwith a channel for interaction with the plug.

In order, starting at the proximal end of the device and proceedingdistally, the device includes the second hollow cylinder, the firsthollow cylinder, and then the base member. Of these elements, the secondhollow cylinder and the base member are attached to and rotate with thefirst wing while the first hollow cylinder, the needle/tubing adapterand the needle are attached to the second wing. Together, the first andsecond hollow cylinders and the base member form a continuous passagewaythat is sized to allow the cylindrical needle guard to axially travelthrough the passageway.

In use, the plug is initially located in the channel of the secondhollow cylinder and the wings are juxtaposed (i.e. positioned in theclosed configuration). Next, the distal tip of the needle is insertedinto the patient. With the needle inserted, the wings are rotated open,causing the second hollow cylinder to rotate relative to the firsthollow cylinder. At the end of this rotation, the channel and slot arealigned. Accordingly, the plug advances distally from the channel andinto the slot. After an injection or withdrawal of fluid from thepatient, the wings are rotated closed. As the healthcare worker closesthe wings, the first hollow cylinder rotates relative to the base memberand when the wings are juxtaposed, the slot in the first hollow cylinderaligns with the groove in the base member. With this alignment, the plug(and needle guard) are free to advance distally until the needle guardis positioned over the distal tip of the needle.

The butterfly needle device can further include a locking mechanism tolock the needle guard in place once the needle guard has advanced intoposition covering the distal tip of the needle. In greater structuraldetail, the locking mechanism can include a deflectable tab that extendsfrom the needle guard and terminates in a tab end. Specifically, the tabis deflectable from a first position wherein the tab end is distancedfrom the needle axis by a distance d₁, to a second position wherein thetab end is distanced from the needle axis by a distance d₂, with d₁>d₂.A catch recess is formed in the base member to receive the tab when theneedle guard is in position covering the distal tip of the needle. Thecatch recess prevents proximal movement of the tab, and thus, once thetab is in the catch recess, the needle guard is locked over the needleto protect against accidental needle sticks or inadvertent re-use.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of this invention, as well as the invention itself,both as to its structure and its operation, will be best understood fromthe accompanying drawings, taken in conjunction with the accompanyingdescription, in which similar reference characters refer to similarparts, and in which:

FIG. 1 is a perspective view of a butterfly needle device having apassive needle protection system shown;

FIG. 2 is an exploded perspective view of a butterfly needle devicehaving a passive needle protection system;

FIG. 3 is a perspective view of a butterfly needle device having apassive needle protection system shown with the wings in the openconfiguration;

FIG. 4 is a perspective view of a butterfly needle device having apassive needle protection system shown with the wings in the closedconfiguration and the needle guard positioned to cover the distal tip ofthe needle;

FIG. 5 is a cross sectional view of a butterfly needle device as seenalong line 5-5 in FIG. 1;

FIG. 6 is a cross sectional view of a butterfly needle device as seenalong line 6-6 in FIG. 4; and

FIG. 7 is a cross sectional view of a butterfly needle device as seenalong line 7-7 in FIG. 4.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring initially to FIG. 1, a butterfly needle device having apassive needle protection system is shown and generally designated 10.FIG. 1 shows the device 10 configured for delivery to the healthcareworker. As shown, the device 10 is typically shipped with a protectivecap 12 that covers and protects the needle tip during handling. In theembodiment of the device 10 shown, a needle/tubing adapter 14 isincluded allowing the device 10 to be connected to a universal Luer lockusing microtubing, which in turn can be connected to an IV set, bloodcollection holder, syringe, etc.

As best seen in FIG. 2, the device 10 includes an elongated needle 16that has a proximal end 18, a distal tip 20 and defines a needle axis22. The device 10 further includes a first winged element 24, which inthis case is formed with a hollow, cylindrical base member 26. Asfurther shown, the first winged element 24 also includes a substantiallyflat first wing 28 that is attached to, and extends radially from, thecylindrical base member 26. During assembly of the device 10, the basemember 26 is disposed over the needle 16 and centered on the needle axis22.

Continuing with reference to FIG. 2, it can be seen that the device 10also includes a second winged element 30, which for the embodiment shownis formed with a first hollow cylinder 32. As further shown, the secondwinged element 30 further includes a substantially flat second wing 34that is attached to, and extends radially from, the first hollowcylinder 32. During assembly of the device 10, the first hollow cylinder32 is disposed over the needle 16 (proximal to the base member 26) andis centered on the needle axis 22.

FIG. 2 further shows that the device 10 includes a hollow, cylindricalneedle guard 36 that is disposed over the needle 16 and positionedcoaxially with the base member 26 and the first hollow cylinder 32 (whenassembled). As shown, the needle guard 36 is sized to pass through boththe base member 26 and the first hollow cylinder 32, thus allowing forreciprocal axial movement of the needle guard 36 relative to both thebase member 26 and first hollow cylinder 32.

Also shown in FIG. 2, the butterfly needle device 10 can include ahelical spring 38 to bias the needle guard 36 distally relative to thebase member 26 and first hollow cylinder 32. When the device 10 isassembled, the proximal end 18 of the needle 16 is attached to theneedle/tubing adapter 14, which in turn, includes a tapered distalportion for mounting the adapter 14 to the second winged element 30 viasocket 40. A stop (not shown) can be formed on the adapter 14 to limitthe rotation of the wings 28, 34 during opening to thereby prevent thewinged elements 24, 30 from pinching the patient's skin. Thus, thesecond winged element 30 which includes the first hollow cylinder 32 andthe socket 40 rotate together relative to the first winged element 24.After device 10 assembly, the helical spring 38 is interposed betweenthe needle guard 36 and the needle/tubing adapter 14. With thisstructural combination, the needle guard 36 is biased in the distaldirection relative to the needle 16, the needle/tubing adapter 14, thefirst winged element 24 and the second winged element 30.

As indicated above with reference to FIG. 1, the device 10 is initiallyprepared in a closed configuration wherein the first wing 28 and secondwing 34 are juxtaposed. This closed configuration allows the healthcareworker to easily grip the wings 28, 34 during insertion of the needle 16(needle 16 shown FIG. 2) into the patient. With the needle 16 inserted,the second wing 34 is rotated relative to the first wing 28 to an openconfiguration (shown in FIG. 3) in which the wings 28, 34 are displacedfrom each other by approximately one-hundred eighty degrees (180°). Thisopen configuration allows the wings 28, 34 to be taped to the patient(tape and patient not shown) to stabilize the device 10 while fluids areintroduced into or withdrawn from the patient. Next, the tape is removedand the second wing 34 is rotated relative to the first wing 28 toreconfigure the device 10 back into the closed configuration (shown inFIG. 4) in which the wings 28, 34 are once again juxtaposed. FIG. 4shows that at the end of the closed-open-closed cycle, the needle guard36 has advanced into a distal position wherein the needle guard 36covers and protects the distal tip 20 of the needle 16.

The device 10 further includes a mechanism for regulating the distalmovement of the needle guard 36 during the closed-open-closed cycle.Specifically, as best seen in FIG. 2, the needle guard 36 is formed witha plug 42 that extends radially outward from the cylindrical portion ofthe needle guard 36. The plug 42 is sized to move within an axiallyaligned groove 44 that is formed on the inner wall 46 of the base member26. For the embodiment shown, the axially aligned groove 44 extends fromthe proximal end 47 of the base member 26 to the distal end 48 of thebase member 26. Also shown in FIG. 2, the first hollow cylinder 32 hasan inner wall 50 that is formed with an axially aligned slot 52 forinteraction with the plug 42. In addition, the first winged element 24includes a second hollow cylinder 54 that is centered on the needle axis22 proximal to the first hollow cylinder 32, after assembly of thedevice 10. As best seen with cross-reference to FIGS. 2 and 5, thesecond hollow cylinder 54 has an inner wall 56 that is formed with achannel 58 for interaction with the plug 42.

With cross-reference to FIGS. 1 and 5, it can be seen that the plug 42is initially located in the channel 58 of the second hollow cylinder 54and the wings 28, 34 are juxtaposed (i.e. positioned in the closedconfiguration). In this configuration, the cap 12 can be removed and thedistal tip 20 of the needle 16 can be inserted into the patient. Withthe needle 16 inserted, the wings 28, 34 are rotated open to theconfiguration shown in FIG. 3. This rotation causes the second hollowcylinder 54 to rotate relative to the first hollow cylinder 32 (shown inFIG. 2). At the end of this rotation, the channel 58 and slot 52 (shownin FIG. 2) are aligned. Accordingly, the plug 42 advances distally fromthe channel 58 and into the slot 52. After an injection or withdrawal offluid from the patient, the wings 28, 34 are rotated closed. As thewings 28, 34 are closed, the first hollow cylinder 32 rotates relativeto the base member 26 and when the wings 28, 34 are juxtaposed as shownin FIGS. 1 and 4, the slot 52 (see FIG. 2) in the first hollow cylinder32 aligns with the groove 44 in the base member 26. With this alignment,the plug 42 (and needle guard 36) is free to advance distally until theneedle guard 36 is positioned over the distal tip 20 of the needle 16,as shown in FIG. 4.

With cross-reference now to FIGS. 2, 6 and 7, it can be seen that thebutterfly needle device 10 can further include a locking mechanism tolock the needle guard 36 once the needle guard 36 has advanced intoposition covering the distal tip 20 of the needle 16. The lockingmechanism can also lock the wings 28, 34 in the closed configuration.For the embodiment shown, the locking mechanism includes a deflectabletab 60 that extends from the cylindrical portion of the needle guard 36and terminates in a tab end 62. Specifically, the tab 60 is deflectablefrom a first position wherein the tab end 62 is distanced from theneedle axis 22 by a distance d₁, to a second position wherein the tabend 62 is distanced from the needle axis 22 by a distance d₂, withd₁>d₂. FIG. 7 shows that a catch recess 64 is formed in the base member26 to receive the tab 60 when the needle guard 36 is in positioncovering the distal tip 20 of the needle 16. The catch recess 64prevents proximal movement of the tab 60, and thus, once the tab 60 isin the catch recess 64, the needle guard 36 is locked over the needle 16to protect against accidental needle sticks or inadvertent re-use.

To lock the wings 28, 34, the second winged element 30 can include alocking cylinder 66 that is positioned distally relative to the basemember 26 and centered on the axis 22 when the device 10 is assembled.The locking cylinder 66 is formed with a keyway 68 that is aligned withthe groove 44 when the wings 28, 34 are juxtaposed. When the needleguard 36 is in a distal position covering the tip 20 of the needle 16, aportion of the plug 42 is in the keyway 68 and a portion of the plug 42is in the groove 44 preventing rotational movement of wing 28 relativeto wing 34.

While the particular devices and methods as herein shown and disclosedin detail are fully capable of obtaining the objects and providing theadvantages herein before stated, it is to be understood that they aremerely illustrative of the presently preferred embodiments of theinvention and that no limitations are intended to the details ofconstruction or design herein shown other than as described in theappended claims.

1. A butterfly needle device having a passive needle protection systemcomprising: an elongated needle having a proximal end and a distal tip,said needle defining an axis; a hollow, cylindrical base member disposedover said needle and centered on said axis; a first wing extending fromsaid cylindrical base member; a second wing positioned in saidcylindrical base member for rotation about said axis relative to saidfirst wing between a closed configuration wherein said wings arejuxtaposed and an open configuration wherein said wings are displacedfrom each other by approximately one-hundred eighty degrees (180°); ahollow cylindrical needle guard disposed on said needle and positionedcoaxially with said base member for reciprocal axial movement relativethereto, with one of said base member and said needle guard formed witha plug and the other formed with an axially aligned groove forinteraction with said plug; a means for biasing said needle guarddistally relative to said base member; and a means for aligning saidplug with said groove after said wings have been cycled from said closedconfiguration to said open configuration and then back to said closedconfiguration to allow distal advancement of said needle guard relativeto the needle after said cycle to cover and protect said distal tip ofsaid needle with said needle guard.
 2. A butterfly needle device asrecited in claim 1 further comprising a needle/tubing adapter attachedto said proximal end of said needle, and wherein said biasing meanscomprises a spring disposed between said needle/tubing adapter and saidneedle guard.
 3. A butterfly needle device as recited in claim 1 whereinsaid plug extends radially from said needle guard and said base memberhas an inner wall formed with said axially aligned groove.
 4. Abutterfly needle device as recited in claim 3 wherein said aligningmeans comprises a hollow cylinder attached to said second wing andpositioned coaxially with said guard, said hollow cylinder formed with aslot for interaction with said plug to rotate said guard relative tosaid base member to align said plug with said groove after a movement ofsaid second wing relative to said first wing.
 5. A butterfly needledevice as recited in claim 4 wherein said hollow cylinder is a firsthollow cylinder and said aligning means further comprises a secondhollow cylinder attached to said first wing and positioned coaxiallywith said guard, said second hollow cylinder formed with a channel forinteraction with said plug to rotate said guard relative to said firsthollow cylinder to align said plug with said slot after a movement ofsaid second wing relative to said first wing.
 6. A butterfly needledevice as recited in claim 1 further comprising a means for locking saidneedle guard in position covering said distal tip of said needle.
 7. Abutterfly needle device as recited in claim 6 wherein said locking meanscomprises a tab extending from said needle guard to a tab end, said tabdeflectable from a first position wherein said tab end is distanced fromsaid axis by a distance d₁, to a second position wherein said tab end isdistanced from said axis by a distance d₂, with d₁>d₂, said lockingmeans further comprising a catch recess formed in said base member toreceive said tab and lock said needle guard.
 8. A butterfly needledevice having a passive needle protection system comprising: anelongated needle having a proximal end and a distal tip, said needledefining an axis; a hollow base member disposed over said needle andformed with an axially aligned groove; a first wing extending from saidcylindrical base member; a second wing positioned on said base member; ahollow cylindrical needle guard disposed on said needle and positionedcoaxially with said base member for reciprocal axial movement relativethereto, said needle guard formed with a plug for movement in saidaxially aligned groove; a spring for biasing said needle guard distallyrelative to said base member; and a hollow cylinder attached to saidsecond wing and positioned proximal to said base member, said hollowcylinder formed with a slot for holding said plug to rotate said guardabout said axis relative to said base member and align said plug withsaid groove after a pre-selected movement of said second wing relativeto said first wing.
 9. A butterfly needle device as recited in claim 8further comprising a means for locking said needle guard in positioncovering said distal tip of said needle.
 10. A butterfly needle deviceas recited in claim 9 wherein said locking means comprises a tabextending from said needle guard to a tab end, said tab deflectable froma first position wherein said tab end is distanced from said axis by adistance d₁, to a second position wherein said tab end is distanced fromsaid axis by a distance d₂, with d₁>d₂, said locking means furthercomprising a catch recess formed in said base member to receive said taband lock said needle guard.
 11. A butterfly needle device as recited inclaim 8 further comprising a means for locking said first wing in afixed position relative to said second wing after said pre-selectedmovement of said second wing relative to said first wing.